Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention

Angioplasty Clinical Trial

Official title:

Feasibility and Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention (PCI) in a Tertiary Care Hospital in Karachi, Pakistan.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02214082
• Other study ID #: TIH-Cardio-001
• Status: Completed
• Phase: N/A
• First received: August 9, 2014
• Last updated: July 19, 2017
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: July 2017
• Source: Indus Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study intends to determine if there is any difference in the occurrence of major adverse cardiology events in patients discharged on the same day as their elective cardiac angioplasty or discharged one day after their angioplasty.

Hypothesize that same day discharge is as safe as a day later discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria: :

• Low risk lesion (according to the ACC classification)

• Normal Pre Catheterization laboratory investigation

• Procedure performed before 3 pm

• procedure performed with = 6 French guiding Catheter

• EF = 35%

• living at a distance of within 15 kilometers from hospital

• caregiver present at home

• elective procedure

Exclusion Criteria:

• Acute PCI

• high risk lesions (according to the ACC classification)

• deranged Pre Catheterization laboratory investigations

• Age >70

• Severe LV dysfunction, CVA

• procedure to be performed with a guiding catheter >6F

• Use of IIb/IIIa inhibitor

• Creatinine clearance of < 50

Related Conditions & MeSH terms

• Angioplasty
• Coronary

Intervention

Other:
• Same Day Discharge
This group will be discharged home, on the same day after their elective angioplasty

Locations

Country	Name	City	State
Pakistan	The Indus Hospital	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Indus Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		Within 30 days post angioplasty
Primary	Number of patients who require a 2nd angioplasty		within 30 days of 1st angioplasty
Primary	Number of patients with bleed from the angioplasty site		within 30 days post angioplasty
Secondary	number of hospital re-admissions		within 30 days of initial angioplasty